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Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg

Information source: Mylan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg (Drug); Macrobid® Capsules 100 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Mylan Pharmaceuticals

Official(s) and/or principal investigator(s):
Thomas S Clark, M.D., Principal Investigator, Affiliation: Kendle International Inc.

Summary

The objective of this study was to investigate the bioequivalence of Mylan nitrofurantoin monohydrate/macrocrystals capsules to Procter & Gamble Macrobid capsules following a single, oral 100 mg (1 x 100 mg) dose under fed conditions.

Clinical Details

Official title: Single-Dose Food In Vivo Bioequivalence Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules (100 mg; Mylan) and Macrobid Capsules (100 mg; Procter & Gamble) in Healthy Volunteers.

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- healthy, adult subjects, 18 years and older

- able to swallow medication

Exclusion Criteria:

- institutionalized subjects

- history of any significant disease

- use of any prescription or OTC medications within 14 days of start of study

- received any investigational products within 30 days prior to start of study

Locations and Contacts

Kendle International Inc., Morgantown, West Virginia 26505, United States
Additional Information

Mylan Pharmaceuticals Inc. - Clinical Trial Results

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Starting date: July 2002
Last updated: November 19, 2009

Page last updated: August 23, 2015

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